FIDANACOGENE ELAPARVOVEC
UNII 413EU9081Y

Substance Identification & Data

This profile provides standardized clinical and technical data for Fidanacogene Elaparvovec, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 413EU9081Y.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 1954659-47-2 and the RxNorm Concept ID (RxCUI) N/A. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code

413EU9081Y

CAS Registry Number

1954659-47-2

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

FIDANACOGENE ELAPARVOVEC

Official standardized name for this substance within the FDA UNII nomenclature system.

NCI Thesaurus

C171800

National Cancer Institute reference terminology for clinical and research data.

INN ID

10798

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

EF-63

Identifier assigned by the United States Adopted Names Council.

Substance Type

structurallyDiverse

ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Fidanacogene Elaparvovec. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

FDA Official Name

FIDANACOGENE ELAPARVOVEC

Common Names & Synonyms

A NON-REPLICATING ADENO-ASSOCIATED VIRUS SEROTYPE 2 (AAV2) EXPRESSING THE PADUA VARIANT (R338L) OF HUMAN COAGULATION FACTOR IX (F9, FACTOR IX, FIX), UNDER THE CONTROL OF THE LIVER-SPECIFIC APOLIPOPROTEIN E (APO E) ENHANCER/ALPHA1-ANTITRYPSIN (HAAT) PROMOTER (APOE/HAAT), AND ALL AAV GENES ENCODING VIRAL PRODUCTS DELETE

AAV8 HFIX19

FIDANACOGENE ELAPARVOVEC [INN]

FIDANACOGENE ELAPARVOVEC [USAN]

FIDANACOGENE ELAPARVOVEC [WHO-DD]

PF-06838435

RAAV-SPARK100-HFIX-PADUA

SPARK 101

SPK-FIX PADUA